MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770602Y
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality was confirmed; the probe¿s is giving a poor image.The site rite 8 was visually inspected upon receipt and was found to be in good physical condition.The probe¿s is giving a poor image due to an internal failure.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Found during evaluation: the probe¿s is giving a poor image due to an internal failure.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT PROBE
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12371297
• Report Number: 3006260740-2021-03529
• Device Sequence Number: 4115311
• Product Code: IYO
• UDI-Device Identifier: 00801741138201
• UDI-Public: (01)00801741138201
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9770602Y
• Device Catalogue Number: 9770602Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other